Topiramate NDC 65862-173

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-173Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0173Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65862-173-05	65862017305	500 TABLET, FILM COATED in 1 BOTTLE (65862-173-05)Marketed from Apr 11, 2022
65862-173-60	65862017360	60 TABLET, FILM COATED in 1 BOTTLE (65862-173-60)Marketed from Mar 27, 2009
65862-173-99	65862017399	1000 TABLET, FILM COATED in 1 BOTTLE (65862-173-99)Marketed from Apr 11, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Topiramate
Generic name (nonproprietary): topiramate
Active ingredients: Topiramate — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078462
Marketing start: Mar 27, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65862-173_67afee59-3d84-418f-832c-d00abd43fe5bSPL ID 67afee59-3d84-418f-832c-d00abd43fe5bSPL set ID 32b48ea0-a215-43b8-83b4-a5435a686d68RxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0365862171603, 0365862172600

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465862017305 followed by a unit qualifier and the quantity

Package 65862-0173-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 24, 2026.

Indications (excerpt from the label)

Topiramate tablets are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy E…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078462

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078462
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-171
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-172
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8594
Topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-174
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8595
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-443
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-471
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8593